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Clinical Trials: What are States Doing?
April 2008 Update

What is a Clinical Trial?

A clinical trial is a research study on human patients to test the safety and effectiveness of new treatments.  These trials offer patients access to new and potentially life saving drugs and cures. 

The dramatic progress made in treating childhood cancers in recent years, is attributable, in part, to clinical trials, because 60 percent of all children with cancer are enrolled in some kind of trial.  A ten percent drop in breast cancer mortality for women  under the age of 50 is said to be the result of clinical trials research conducted in the 1970's. 

Who Enrolls in Clinical Trials?

Only two to three percent of eligible adult patients enroll in clinical trials.  For cancer patients, clinical trials are often the last resort after exhausting all other approved means of treatment.  

Insurance Coverage for Clinical Trials

Typically, when a patient enrolls in a clinical trial, the cost of tests, procedures, drugs and any research activity directly associated with the investigation, are covered by the group sponsoring the trial, such as a pharmaceutical company or the National Cancer Institute.   However, because some health plans define clinical trials as "experimental" or "investigational," health insurance coverage may or may not include some or all of the costs of  "routine patient care," such as the doctor visits, hospital stays, tests and x-rays, that a patient would normally receive whether or not they were enrolled in a trial. 

Nevertheless, a growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of the routine medical care a patient receives as a participant in a clinical trial.

Advantages:

For cancer patients, properly designed and conducted clinical trials represent an important therapeutic option, as well as a critical means of advancing medical knowledge.  Lack of insurance coverage is a barrier to patients who might otherwise participate.  Sixty percent of patients in one survey cited fear of insurance denial as a major reason for not participating in clinical trials.  And finally, a recent study found only a slight increase in treatment costs for adult clinical trial patients compared to nonparticipants--$35,418 versus $33,248. 

Disadvantages:

Even though the same recent study found only a slight increase in treatment costs, the 6.5 percent increase between participants and nonparticipants in clinical trials translated into an additional $16 million in 1999 spent on treatment costs for the 19,000 adult patients enrolled in National Cancer Institute-sponsored clinical trials.  These additional insurance costs, like other mandated benefits and services, may result in higher insurance premium rates, which are often cost-shifted onto workers in the form of higher deductibles and copayments.  

Definitions of Phases:

A clinical trial study is conducted in four phases.

Phase I:  Research is conducted on a small group of volunteers (20 to 80 people) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

Phase II: The experimental drug or treatment is given to or a procedure is performed on a larger group of people (100 to 300 individuals) to further measure its effectiveness and safety.

Phase III:  Further research is conducted to confirm the effectiveness of the drug, treatment or procedure, monitor the side effects, compare commonly used treatments and collect information on safe use.  Phase III trials are typically conducted on 1,000 to 3,000 individuals.

Phase IV:  After the drug, treatment or medical procedure is marketed, investigators continue testing to determine the effects on various populations and whether there are side effects associated with long-term use.

Summary of State Laws

Table One provides a summary of the 20 states that have enacted laws regarding mandated coverage of clinical trials.

Table One Clinical Trials Laws April 2006
State Year of Enactment Bill Number and/or Citation	Who is Required to Pay?	What Services or Benefits are Covered?	Other Key Criteria:
Arizona (2000) Senate Bill 1213 20-2328	Hospital or medical service corporations, benefit insurers, health care service organizations, disability insurers, group disability insurers and accountable health plans	Patient costs associated with participation in Phase I through IV cancer clinical trials.	Trail must be reviewed by an Institutions Review Board in AZ. Health professional must agree to accept reimbursement from insurer as payment in full. Only covers trial when no clearly superior nonivestigational treatment exists. Trail must be in AZ.
California (2000) Senate Bill 37	All California insurers, including Medicaid and other medical assistance programs	Routine patient care costs associated with Phase I through IV cancer clinical trials.	May restrict coverage to services in CA.
Connecticut (2001) Senate Bill 325 Public Act 01-171	Private insurers, individual and group health plans	Routine patient care costs associated with cancer clinical trials.	Prevention trials are covered only in Phase III and only if involve therapeutic intervention. Insurer may require documentation of the likelihood of therapeutic benefit, informed consent, protocol information and/or  summary of costs.
Delaware (2001)Senate Bill 181	Every group of blanket policy, including policies or contracts issued by health service corporations	Routine patient care costs for covered persons engaging in clinical trials for the treatment of life threatening diseases under specified conditions.	Trial must have therapeutic intent and enroll individuals diagnosed with the disease. Trial must not be designed exclusively to test toxicity or disease pathophysiology.
Georgia* (1998) 33-24-59.1	Insurers and the state health plan	Routine patient costs incurred in Phase II and III of prescription drug clinical trial programs for the treatment of children's cancer.	For the treatment of cancer that generally first manifests itself in children under the age of 19.
Illinois (1999) House Bill 1622 (amended 2004) Senate Bill 2339 Public Act No. 93-1000 20 ILCS 1405/56.3**	HMOs and individual/group insurance policies to offer coverage to the applicant or policyholder (2004 amendment: Plans may not be canceled or non renewed based on an individual's participation in a qualified clinical trial)	Routine patient care if the individual participates in an approved Phase II through IV cancer research trial.	Coverage benefit can have annual limit of $10,000. Trial must be conducted at multiple sites in state. Primary care MD must be involved in coordination of care. Researchers must submit results of trial for publication in nationally recognized scientific literature.
Louisiana (1999) RS 22:230.4	HMOs, PPOs, State Employee Benefits Program and other specified insurers	Patient costs incurred in Phase II through IV cancer clinical trials.	Only covers costs when no clearly superior, noninvestigational approach exists. Available data must support reasonable expectation that the treatment will be as effective as the noninvestigational alternative. Patient must  sign an Institutional Review Board-approved consent form.
Maine (2000)  24-A-4310	Managed care organizations and private insurers	Routine patient care costs associated with clinical trial.	Participation must offer  meaningful potential for significant clinical benefit. Referring physician must conclude that trial participation is appropriate.
Maryland*** (1998) Chap 146-15-827	Private insurers and other specified managed care organizations.	Patient costs for Phase I through IV cancer treatment, supportive care, early detection, and prevention trials.  Phase II through IV for other life-threatening conditions, with Phase I considered on a case-by-case basis.	There is no clearly superior, nonivestigational alternative. The data provide a reasonable expectation that the treatment will be as least as effective as the alternative.
Massachusetts (2002) Chap 176A Sec 8X	All health plans issued or renewed after Jan. 1, 2003	Patient care services associated with all phases of qualified cancer clinical trials.	Insurers must provide payment for services that are consistent with the usual and customary standard of care provided under the trial's protocol and that would be covered if the patient did not participate in the trial.
Missouri (2002) 376.429 (2006)- Phase II SB 567 & 792	All health benefit plans operating in the state	Routine patient care costs as the result of Phase II, III or IV clinical trials for the prevention, early detection, or treatment of cancer.	There must be identical or superior nonivestigational treatment alternatives available before providing clinical trial treatment, and there must be a reasonable expectation that the trial will be superior to the alternatives. Requires coverage of FDA-approved drugs and devices even if they have not be approved for use in treatment of patient's particular condition.
New Hampshire (2000) 415:18	Private insurers and specified managed care plans	Medically necessary routine patient care costs incurred as a result of a treatment for Phase I through IV cancer clinical trial or trial for a life-threatening disease.	Coverage for Phases I or II decided on case-by-case basis. Coverage is required for services needed to administer drug or device under evaluation. Coverage is required for routine patient care associated with drugs or devices which are not subject of trial, as long as they have been approved by FDA.
Nevada (2003) (amended 2005)SB 29 NRS 695G.173	All health insurance insurers, medical service corporations, HMOs and managed care organizations	Patient costs associated with Phase I through IV cancer or chronic fatigue clinical trial	Healthcare facility and personnel must have experience and training to provide the treatment in a capable manner. There must be no medical treatment available which is considered a more appropriate alternative medical treatment than the medical treatment provided in the clinical trial. There must be a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment. Amendment revises type of medical treatment covered.
New Mexico (2002) (amended 2004 to delay repeal until July 1, 2009) 59A-22-43	A health insurer; a nonprofit health service provider; a HMO; a managed care organization; a provider service organization; or the state's medical assistance program.	Routine patient care costs incurred as a result of the patient's participation in a phase II, III or IV cancer clinical trial.	Must be undertaken for the purposes of the prevention of reoccurrence of cancer, early detection or treatment of cancer for which no equally or more effective standard cancer treatment exists.  Must not be designed exclusively to test toxicity or disease pathophysiology and it has a therapeutic intent. Must be  provided as part of a scientific study of a new therapy or intervention and is for the prevention of reoccurrence, early detection, treatment or palliation of cancer in humans and in which includes specific provisions of scientific study.
New Mexico (2001) 59A-22-43	Private insurers, specified managed care plans, and Medicaid and other state medical assistance programs	Routine patient care costs incurred as result of Phase I through IV cancer clinical trial.	Effective through July 1, 2004. Trial must have therapeutic intent. Reasonable expectation that investigational treatment will be at least as effective as standard treatment.
North Carolina (2001) ? 58-3-255	All health insurance plans and teachers' and state employees' comprehensive major medical plan.	Medically necessary costs of health care services associated with Phase II through IV of covered clinical trials.	Patients suffering from a life-threatening disease or chronic condition may designate a specialist who is capable of coordinating their health care needs.
Rhode Island (1994, 1997) 94-S 2623B 97-S  1A am	Private insurers and specified managed care plans	Coverage for new cancer therapies if treatment is provided under Phase II through IV cancer clinical trial.
Tennessee (2005) HB 837	All health benefit plans	Routine patient care costs related to Phase I through IV cancer clinical trial.	Treament must involve drug that is exempt under federal regulations from a new drug application, or approved by: NIH, FDA in form of new drug application, DOD, or VA.
Vermont (2001) (amended 2005 to remove March 1, 2005 sunset provision) Chap 107 ? 4088b HB 6	All health insurance policies and health benefit plans, including Medicaid	Routine patient care costs incurred during the participation in a cancer clinical trial.	Providers and insurers required to participate in a cost analysis to determine impact of the program on health insurance premiums. Amended law allows for participation in trial outside of Vermont if patient notifies health benefit plan prior to participation, and no clinical trial is available at Vermont or New Hampshire cancer care providers.
Virginia (1999) ? 38.2-3418.8	Private insurers, specified managed care plans, and public employee health plans	Patient costs incurred during the participation in Phase II through IV cancer clinical trials. Coverage provided on a case-by-case basis for Phase I.	There must be no clearly superior, nonivestigational alternative. Data must provide a reasonable expectation that the treatment will be at least as effective as the alternative.
West Virginia (2003) ?9-2-12	Individual and group insurers, health service corporations, health care corporations, HMOs, public employees insurance agency, Medicaid and the children's health insurance program	Patient costs associated with the participation in Phase II through IV clinical trial for treatment of life-threatening condition or the prevention, early detection and treatment of cancer.	Facility and personnel providing the treatment are capable of doing so by virtue of their experience, training and volume of patients treated to maintain expertise. There must be no clearly superior, noninvestigational treatment alternative. Data provide a reasonable expectation that the treatment will be more effective than the noninvestigational treatment alternative.
Wisconsin AB 617 (2006) Act 194	Any health insurance plan offered by the state, any self-insured plans	Routine patient care costs incurred during the participation in all phases of a cancer clinical trial. No policy, plan, or contract may exclude coverage for the cost of any routine patient care that is administered to an insured in a cancer clinical trial satisfying the criteria under par. (c) and that would be covered under the policy, plan, or contract if the insured were not enrolled in a cancer clinical trial.	Trial must meet all criteria: 1. The purpose is to test whether the intervention potentially improves the trial participant’s health outcomes. 2. The treatment provided as part of the trial is given with the intention of improving the trial participant’s health outcomes. 3. The trial has therapeutic intent and is not designed exclusively to test toxicity or disease pathophysiology. 4. The trial does one of the following: a. Tests how to administer a health care service, item, or drug for the treatment of cancer. b. Tests responses to a health care service, item, or drug for the treatment of cancer. c. Compares the effectiveness of health care services, items, or drugs for the treatment of cancer with that of other health care services, items, or drugs for the treatment of cancer. d. Studies new uses of health care services, items, or drugs for the treatment of cancer. 5. The trial is approved by one of the following: a. A National Institute of Health, or one of its cooperative groups or centers, under the federal department of health and human services; federal food and drug administration; federal department of defense; federal department of veterans affairs.
Wyoming SF 024 (2008 budget session)	All health insurance policies, contracts, and certificates providing coverage to any resident of this state.	Routine patient care for a person enrolled in a Phases II- IV clinical trial.  Includes a medical service or treatment that is a benefit under a health plan that would be covered if the patient were receiving standard cancer treatment; or a drug provided to a patient during a cancer clinical trial, other than the drug that is the subject of the clinical trial, if the drug has been approved by the federal food and drug administration for use in treating the patient's particular condition.	Trial must also be approved by NIH, FDA, Dept. of Defense, or Dept. of Veterans Affairs.  The medical treatment must be provided by a licensed health care provider operating within the scope of his/her license in a facility whose personnel has the experience and training necessary to provide the treatment in a competent manner. The clinical trial participant must have signed an informed consent document prior to starting the trial.

*In 2002, all major insurers in Georgia agreed to cover routine patient care costs associated with Phase I, II, III, or IV cancer clinical trials.  Trials include those that involve a drug that is currently exempt under federal regulations from a new drug application or those that are approved by specified federal agencies or a local institutional review board.  The agreement also provides for the coverage of cancer screens and examinations in accordance with the most recently published guidelines and recommendations established by any nationally recognized health care organization (see below).

**Illinois Executive Branch Administrative Code (20 ILCS 1405/1405-20) required the Department of Insurance to conduct an analysis and study of costs and benefits derived from the implementation of the coverage requirements for investigational cancer treatments. The study covered the years 2000 through 2002 and included an analysis of the effect of the coverage requirements on the cost of insurance and health care, the results of the treatments to patients, the mortality rate among cancer patients, any improvements in care of patients, and any improvements in the quality of life of patients.

***A 2003 Maryland law (S 128) repealed a reporting requirement for insurers, nonprofit health service plans, and HMOs to submit a report that described the trials covered during the previous year.

Sources: National Cancer Institute, Health Policy Tracking Service.

Summary of Other Actions

Table Two summarizes the special agreements some states have arranged with insurance companies to voluntarily provide coverage for clinical trials. 

Table Two Special Agreements
State (Year Agreement Became Effective) Web Address of Agreement	Who is Required to Pay?	What Services or Benefits are Covered?	Other Key Criteria:
Georgia (2002) Georgia Cancer Coalition	All major insurers	Routine patient care costs associated with Phase I through IV cancer clinical trials.	Trials include those that involve a drug that is currently exempt under federal regulations from a new drug application or those that are approved by specified federal agencies or a local institutional review board. Provides for the coverage of cancer screens and examinations in accordance with the most recently published guidelines and recommendations established by any nationally recognized health care organization.
Michigan (2002) Michigan Consensus Agreement	Private insurance plans, HMOs and Medicaid	Routine patient care  costs associated with Phase II and III cancer clinical trials.	Coverage for Phase I trials is under consideration.
New Jersey (1999) New Jersey Consensus Agreement	All insurers	Routine patient care costs associated with all phases of cancer clinical trials.
Ohio (1999) Ohio Med Plan	State employees on Ohio Med Plan	Routine patient care costs associated with Phase II and III cancer treatment clinical trials.	Preauthorization is required for clinical trial participation.

Federal Activity

In 2000, Medicare began covering beneficiaries patient care costs in clinical trials.  While many state Medicaid programs have no legal requirements to cover clinical trials costs, many do cover all or some of the costs.

To legislators and legislative staff: For more information please contact Karmen Hanson at health-info@ncsl.org